ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arterio
Check against the official notice below — it lists the full affected range.
Medtronic is recalling specific lots of the PowerCross .018 Over the Wire PTA Dilatation Catheter, a device used to dilate narrowed blood vessels in the legs. During a manufacturing inspection, the company discovered that catheter outer shafts in certain lots were pinched and deformed at the proximal balloon bond. Testing showed these defects caused the device to either fail to inflate properly, deflate slowly, or fail to deflate after expansion.
A total of 315 affected devices were distributed to hospitals and medical facilities in New York, North Carolina, and Washington. The recall involves six specific product lots identified by their UDI, product number, and lot codes. The source document does not specify what steps affected consumers or healthcare providers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.
Reason for recall: Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion. Distribution: NY, NC, WA Quantity: 315 Lot/code info: UDI/Product Lot/Serial Product Number UPN/GTIN Number 00821684046647 A358626 AB18W030100150 00821684046883 A357386 AB18W060100150 00821684046722 A357070 AB18W040100150 00821684046777 A358043 AB18W050040150 00821684046722 A356360 AB18W040100150 00821684046777 A357348 AB18W050040150 00821684046562 A359219 AB18W025040150
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.